Are biological drugs effective and safe in older severe asthmatics?

ABSTRACT

Introduction: The treatment of asthma in older ages follows the recommendations of international guidelines for the management of asthma in younger ages, although older age has always represented an exclusion criterion for eligibility to pharmacological trials. This poses a clinical challenge when deciding whether elderly severe asthmatics are candidates for biological drugs.

Areas covered: The current article has a narrative structure to review the current literature on efficacy and safety of novel pharmacological drugs against immunoglobulins and interleukins that mediate and orchestrate the main inflammatory pathways in severe asthma, in order to explore whether older subjects (i.e. > 65 years of age) are included.

Expert opinion: Asthma in older ages is not a rare entity, and loss of symptom control is common in most advanced ages. Current evidence from randomized clinical trials (RCTs) on the safety of biological drugs in elderly asthmatics is scarce and does not allow drawing definitive conclusions. An urgent call for studies specifically designed for elderly populations is needed, with the purpose to assess the efficacy and safety of target biological therapies in advanced ages. We envision the design of large multi-center clinical trials to decide whether and when geriatric population could benefit from biological therapies.

KEYWORDS:

• Asthma/drug therapy
• anti-asthmatic agents/pharmacology
• antibodies
• monoclonal
• humanized
• pulmonary eosinophilia/drug therapy

Article highlights

• Pharmacological treatment of older severe asthmatics implies a different approach than in young population because of the higher occurrence of comorbidities and polypharmacotherapy, with potential detrimental interactions between different drugs. However, data on efficacy and safety of biological drugs in elderly asthmatics (aged 65 years and over) are scanty.

• Treatment of asthma in the geriatric age follows recommendations that are extrapolated from RCTs performed in younger populations. Since older age has often represented an exclusion criterion for eligibility in RCTs, most current asthma medications have never been tested in elderly asthmatics.

• Although many RCTs on biologic drugs have included subjects up to 80 years of age, a specific age-based analysis has been rarely performed.

• In the elderly, omalizumab shows efficacy with regards to exacerbations, symptoms and lung function. However, some data raise the doubt of lower efficacy and more drug-withdrawn in the most advanced populations. Real life data on the other biologics with regards to the influence of age are limited and do not allow to provide any information.

• The features of geriatric asthma call for a different approach to this pathological condition: the management of asthma in the elderly should switch from a disease-oriented to a dysfunction-oriented behavior, with a multidimensional assessment that takes into account the frequent coexistence of comorbid conditions and the related polypharmacotherapy.

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Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.